SUMMARY

• Engaged in Quality / Compliance with 22 years as a quality & validation engineer assuming responsibilities as a lead/supervisor QE, project manager, quality assurance / control specialist, and business analyst in the FDA / EMEA regulated industries (i.e. Biotech: Pharma, Class 2A/2B/3 Medical Devices, IVD’s, Cosmeceutical and Neutraceuticals).
• 20 years of experience authoring, revising, approving, executing and reporting validation protocols for Computerized Systems, Equipment, Process, Facility/Utility, Test Methods, and Cleaning.
• 18 years of experience developing SDLC documentation and deliverables per ISPE GAMP5 Waterfall and Agile / SCRUM methodology.
• Skilled with DOE’s / feasibility studies / system suitability / engineering studies, applying 6sigma principles / SPC / SQC / TQM and performing gage R&R.
• Skilled at conducting audits, CAPA / IR / DR / OOS / OOT and resolving challenges, applying risk management tools.
• Experienced in project management, performing assessments, providing detailed & executive summaries, developing: project charters, project plans, master validation plans, progress metrics, final reports, and providing recommendations.
• Experienced in managing a project budget, hiring / training employees, resolving issues / conflict, prioritizing project items / resources based on risk & effectiveness, and keeping a dynamic project based on regulatory/management needs, with up to 5 direct reports and 80 indirect reports.
• Experienced in team building, consulting, and training with respect to validation methodology, compliance, regulations, and quality engineering.

TECHNICAL SKILLS

Software/Systems: MS Office (Access, Excel, Word, Power Point, Outlook, Project, Visio), Crystal Reports, MiniTab, Statgraphics / Centurion, Statistica, BM CalMAN, GAGEtrak, Trackwise, SQL Server Mgmt Studio, CATsWeb, Quality Center v10, Test Director, QNX, LabView, AMMS.

ERP/MRP/MES/SCADA: SAP R/3 v4.7 & SAP EP7 ERP6.0 2013 (modules MM, SD, PP, FICO, LO, CS, PL, WM&RF), MfgPRO, various Oracle based ERP/PLM systems, Solidworks ERP module, Wonderware, Allen Bradley, Siemens, Lighthouse, Camstar MES.

EDMS/PLM: MetaPhase, Documentum, Content Management System (TevaDoc), PLM (Agile and IBM PDM), SAP PLM module.

CDS/SDMS/LIMS: Waters Millennium and Empower, Masslynx, Chemstation, Chromeleon, Waters ELN, Labware LIMS, Oracle/Java Cat 5 LIMS, NuGenesis.

Databases/TKTsys/QMS: SQL, Oracle, MS Access, JIRA.

Languages: English and Polish (native), Spanish and French (conversational).

Standards: 21CFR Part 111, 21CFR Part 211 (cGMP), 21CFR Part 58 (GLP), 21CFR Part 820 (QSR), 21CFR Part 11 & Annex 11 (ERES), ANSI/ASQC Z1.4/Z1.9, ICHQ guidelines, EMEA GMP - 91/412/EEC & 91/356/EE, ISO 9001/2/3, ISO13485, ISO 14644, EN45001 / ISO17025, IEC 62304 / IEC 12207 / IEC 15288, 60601-1, ISO 14971, EN 61010 (IVD), IEC 60812 (FMEA), ISO 14001 (environmental), ASME Y14.5 (GD&T), and ASTM E2500.

PROFESSIONAL EXPERIENCE

Sr. Quality / Validation Engineer & Project Manager

Confidential

Responsibilities:

• In the area of DNA and genomic sequencing technology: authoring, executing, reviewing, and approving: TMV’s, IOPQ’s (EQ’s) on production QC systems / instruments (e.g. HPLC, RI, Viscometer, Nikon Vision systems, etc), DOE’s, feasibility / engineering / system suitability studies.
• Performing risk assessments / FMEA on software & computerized systems (e.g. MES, LIMS, robotic systems, microplate reader, etc).
• Authoring, executing, reviewing, and approving SDLC documents including URS, SRS, FRS, SDD, VMP, VP, V&V, IOQ’s test scripts, integration testing, UAT, VSR.
• Directed a team of quality engineers in product integration project.
• Generated Quality and Process / Equipment / Design Validation procedures / procedures / policies.
• Generated dFMEcA and pFMEcA for product lines of an acquired stent manufacturer, “ Confidential ”.
• Performed gap analysis of current manufacturing and design/process against DS, clinical data, and DHF documentation. This included generation of remediation plan for quality relevant documentation, dimensional and functional testing.
• Improved and created inspection points / test methods.
• Reviewed / commented on QP and MP SOP’s and trained QEs and MEs on proper drafting of documents.
• Generated Gage R&R and Test Method Validations including Test Method Validations.
• Trained engineers and generated various tool / test fixture Feasibility, Engineering, and DOE studies.
• Improved / implemented compliance to an existing process.
• Migrated a fully manual process into semi-automated operation.
• Developed a training program for operators, inspectors, and QC leads / supervisors.

Confidential

Project Manager

Responsibilities:

• Generated compliance gap assessment on process, CatsWeb SQL database and SAP per FDA and other global governing agencies (EMEA, HCan, CFDA, CDSCO, MHLW, TGA, MHRA), local site, AMO global, and divisional policies and regulations with respect to product safety & compliance metrics (i.e. Post Market Surveillance, Adverse Events, MDR, monthly, quarterly, and annual regulatory agency submission).
• Generated detailed compliance and technical assessment, reports, and executive summary to management.
• Created 21 CFR Part 820 / ISO 13485 (GxP), 21 CFR Part 11 / Annex 11 (electronic records and electronic signatures or ERES) compliance gap remediation plans and risk assessment, which included implementation and integration with existing technology (i.e. SAP Business Intelligence / Business Objects and Web Client).
• Revised / created procedures and validation SOP’s to comply with divisional policy and GxP / ERES.
• Revised existing process and validation SOP’s to comply with GxP, ERES, global, divisional policy.
• Generated technical Work Instructions (WI) for Adverse Event (AE), MDR, quarterly and annual product safety / complaints trending and data acquisition process between CatsWeb and SAP.
• Tracked and reported on progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
• Managed activities to resolve project issues with team members and project stakeholders: subject matter experts (SME’s), Business Owners (BO’s), and Technical Owners (TO’s).
• Authored / executed validation and verification documentation, GAMP5 SDLC documentation and reported on activities / deliverables pertaining to product trending systems/processes.
• Trained team on strategies for improved trending accuracy between CATSWeb and SAP.

Confidential

Quality Systems Engineer & CSV specialist

Responsibilities:

• Authored Requirement Specifications (i.e. URS, FS, SDS) and Test Scripts for Waters ELN Forms in Quality Center v10 (QC) and resolved associated deviations in QC and TKS.
• Authored associated SDLC documentation: Validation Master Plan (VMP) and Validation Summary Report (VSR).
• Trained technical owners on GxP / ERES requirements and testing scripts.
• Maintained and assured compliance of current / new Computerized & Automated Systems, per local / global policies, SOP’s, regulatory agencies:
• Assured the compliance of businesses, functional and user requirements with respect to system, procedural, interface, data, business, and regulatory requirements.
• Reviewed, trained on, and approved SDLC deliverables such as VMP, user requirement specifications (URS), Functional Design Specifications (FDS), Design Specifications (DS), Software Design Specifications (SDS), Hardware Design Specifications (HDS), IQ / OQ (including UAT, Integration, functional testing) / PQ, vendor audits, Trace Matrix (TM), Summary Report (VSR), Risk Analysis (RA), and Administration / Use/ Maintenance & Periodic Review SOP’s.
• Cultivated communicative rapport with management and executives across QC / R&D Laboratories, RA, IT Compliance, Engineering, Operations / Mfg, Facilities, Maintenance and Metrology (local site and global).
• Ensured the completion and approval of the Software Development Life Cycle phases (SDLC) deliverables for all departments (as stated above), the validation status, approval for system release with respect to implementation and maintained compliance of the system’s validated state after release.
• Led meetings to provide QA SME guidance with respect to site, global, and regulations.
• Identified and resolved issues by employing criticality, risk / severity analysis, and regulatory / business requirements.
• Documented activities issues, severity, risk/severity, and provided progress / issues / action plan reports to upper management.
• Trained users and stakeholders (inc. BO’s and TO’s) on GAMP process, procedural and site / global policies, change control, spreadsheet validation requirements, authoring of SDLC documentation, etc.
• Developed, revised, edited, and implemented validation policies and SOP’s (ERES, Lab Systems, and Equipment Engineering Controls) pertaining to Lab System Assays / Methods, Change Control, System Administration, Maintenance, and Calibration.
• Authored Laboratory Systems / Instruments and Engineering Controls SDLC documents (VMP, FDS, URS, SCS, IQ, OQ, PQ, TM, VSR, Admin SOP, Change Management documents) and executed test scripts.
• Performed periodic review (PR) of software / system, ERES assessments and generated reports.
• Revised and assisted in creation of SOPs with respect to Use, Administration, and Maintenance.
• Reviewed / commented / approved: FMEA’s, specifications, drawings, protocols and data submitted to FDA, corporate, site, and ASTM/ANSI compliance.Generated reports and remediation action items based on gaps / deviations.
• Performed statistical analysis on data gathered by field CQA's and Quality team members.
• Reviewed for compliance and adherence to FDA regulations / standards and device requirement specifications:
• Provided guidance / training based on statistical analysis, FMEA, sampling plan, and compliance to regulations / standards.
• Convened in daily update meetings providing project status, milestones accomplishments, deliverables, and present bottlenecks with proposed resolution.
• Advised management / team on contingency and backup plans to keep in compliance with challenging vendors, suppliers, manufacturers.